(183 days)
The ARCHITECT iPhenytoin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenytoin, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of phenytoin to help ensure appropriate therapy.
The ARCHITECT iPhenytoin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenytoin in human serum or plasma.
The ARCHITECT iPhenytoin assay is a one-step STAT immunoassay for the quantitative measurement of phenytoin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-phenytoin coated paramagnetic microparticles, and phenytoin acridinium-labeled conjugate are combined to create a reaction mixture. The antiphenytoin coated microparticles bind to phenytoin present in the sample and to the phenytoin acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of phenytoin in the sample and the RLUs detected by the ARCHITECT i System optics.
The acceptance criteria and study proving device performance are described below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Precision | Substantially equivalent to the AxSYM Phenytoin assay. |
| Linearity | Substantially equivalent to the AxSYM Phenytoin assay. |
| Interferences | Substantially equivalent to the AxSYM Phenytoin assay. |
| Clinical Performance (Correlation to Predicate) | Correlation coefficient of 0.993 with AxSYM Phenytoin assay. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the clinical performance study. It only mentions "non-clinical performance data" and "clinical performance data."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The study compares the ARCHITECT iPhenytoin assay to a legally marketed predicate device (AxSYM Phenytoin assay), implying the predicate's results are used as the reference, rather than independent expert ground truth establishment for a test set in the traditional sense of image analysis or diagnostic interpretation.
4. Adjudication Method
This information is not applicable and not provided in the document. Adjudication methods are typically used in studies involving human interpretation where discrepancies need to be resolved; this study is an analytical performance comparison of an immunoassay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The ARCHITECT iPhenytoin assay is an in vitro diagnostic device for quantitative measurement of a drug, not a diagnostic imaging or interpretive device that would typically involve human readers.
6. Standalone Performance Study
The entire study described is a standalone performance study in the context of an in vitro diagnostic device. The ARCHITECT iPhenytoin assay's performance (precision, linearity, interferences, and correlation) was evaluated independently and then compared to a predicate device. There is no human-in-the-loop component in the functionality of this immunoassay.
7. Type of Ground Truth Used
The "ground truth" for the clinical performance evaluation was the results obtained from the legally marketed predicate device, the AxSYM Phenytoin assay. The study aimed to demonstrate substantial equivalence by correlating the results of the new device with the predicate.
8. Sample Size for the Training Set
This information is not provided in the document. As an immunoassay, the device relies on chemical and biological reactions rather than machine learning algorithms that typically require dedicated training sets in the computational sense. The "training" for such devices involves assay development and optimization rather than data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of an immunoassay. The development and optimization of the ARCHITECT iPhenytoin assay would involve standard laboratory practices to establish parameters (e.g., reagent concentrations, incubation times) that yield accurate and reproducible results, rather than a "ground truth" derived from a training dataset in the machine learning sense. The performance characteristics (precision, linearity, etc.) are established through validation studies.
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ARCHITECT iPhenytoin
510(k) Summary (Summary of Safety and Effectiveness)
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
KORO 696 The assigned 510(k) number is: _
Preparation Date:
Applicant Name:
Carol Jochum Senior Regulatory Affairs Specialist 100 Abbott Park Rd Abbott Park, IL 60064 Carol.Jochum@abbott.com
Device Name:
Reagents Classification Name: Diphenylhydantoin test system Trade Name: ARCHITECT iPhenytoin Immunoassay Common Name: Diphenylhydantoin test Governing Regulation: 862.3350 Device Classification: Class II Classification Panel: Toxicology Product Code: LGR
Calibrators:
Classification Name: Calibrator, drug specific Trade Name: ARCHITECT iPhenytoin Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.3200 Device Classification: Class II Classification Panel: Toxicology Product Code: DLJ
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Legally marketed device to which equivalency is claimed:
AxSYM Phenytoin (K935375)
Intended Use of Device:
The ARCHITECT iPhenytoin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenytoin, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of phenvtoin to help ensure appropriate therapy.
Description of Device:
The ARCHITECT iPhenytoin assay is a one-step STAT immunoassay for the quantitative measurement of phenytoin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-phenytoin coated paramagnetic microparticles, and phenytoin acridinium-labeled conjugate are combined to create a reaction mixture. The antiphenytoin coated microparticles bind to phenytoin present in the sample and to the phenytoin acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of phenytoin in the sample and the RLUs detected by the ARCHITECT i System optics.
Comparison of Technological Characteristics:
The ARCHITECT iPhenytoin assay is a chemiluminescent microparticle immunoassay (CMIA) method for the quantitative measurement of phenytoin, an anticonvulsant drug, in human serum and plasma. The AxSYM Phenytoin assay utilizes fluorescence polarization immunoassay (FPIA) technology for the measurement of phenytoin, an anticonvulsant drug, in serum or plasma.
Summary of Non-Clinical Performance:
The ARCHITECT iPhenytoin assay is substantially equivalent to the AxSYM Phenytoin assay in terms of precision. linearity and interferences as demonstrated in non-clinical performance data in this 510(k) submission.
Summary of Clinical Performance:
The ARCHITECT iPhenytoin demonstrated substantially equivalent performance to the AxSYM Phenytoin with a correlation coefficient of 0.993.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Abbott Laboratories c/o Ms. Carol Jochum Senior Regulatory Affairs Specialist 100 Abbott Park Road AP6C-2; Dept. 049C Abbott Park, IL 60064
SEP 1 1 2008
Re: K080696
Trade/Device Name: Architect iPhenytoin Immunoassay Regulation Number: 21 CFR 862.3350 Regulation Name: Diphenylhydantoin test system Regulatory Class: Class II Product Code: DIP, LGR Dated: August 25, 2008 Received: August 26, 2008
Dear Ms. Jochum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.v.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):
080696
Device Name: ARCHITECT iPhenytoin
Indication for Use:
Reagents
The ARCHITECT iPhenytoin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenytoin, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of phenytoin to help ensure appropriate therapy.
Calibrators
The ARCHITECT iPhenytoin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenytoin in human serum or plasma.
Prescription Use × (Part 21 CFR 801 Subpart D)
And/Or
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign Off
Div/sigh Sign-Off Office/of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080676
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.